Open Label, Multi-center, Phase I Study of TECLens Quantitative Refractive Crosslinking in Presby… (NCT07208604) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Open Label, Multi-center, Phase I Study of TECLens Quantitative Refractive Crosslinking in Presbyopia-Aged Patients.
Philippines25 participantsStarted 2025-09-30
Plain-language summary
An 'on-eye' UV delivery system for corneal crosslinking can be used safely and effectively to help free presbyopic patients from the need for reading glasses.
Who can participate
Age range40 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 40-65 years
* Healthy cornea
* Refractive error between +4.0 D and -5.0 D
* Phakic or monofocal pseudophakic (≥6 months post IOL placement)
* Visual acuity correctable by ±0.25 D
Exclusion Criteria:
* Corneal dystrophy, scarring, or prior corneal crosslinking
* Astigmatism \>1.0 D
* Active ocular infection, inflammation, or uncontrolled dry eye
* Advanced glaucoma or diabetic retinopathy
* History of delayed corneal healing
* Pregnancy, breastfeeding, or planning pregnancy during study period
* Certain medications (e.g., isotretinoin)
* Recent participation in other investigational drug/device studies (within 30 days)
* Patients with uncontrolled dry eye or surface disease